NCT07521735已完成不适用
SPO2 NEXT GEN VALIDATION STUDY - PHILIPS OPTIMUS
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- SpO2 accuracy
研究概览
简要总结
The purpose of this clinical study is to validate the SpO2 accuracy performance of the sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry.
详细描述
To validate the SpO2 accuracy of the SpO2 sensors under test with the Philips MRI Patient Monitoring Pulse Oximetry Subsystem during non-motion conditions over the range of 70-100% SaO2, when compared with the reference SaO2 obtained from CO-Oximetry analysis of arterial blood samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must have the ability to understand and provide written informed consent.
- •Participant is an adult between 18-50 years of age.
- •Participant must be willing and able to comply with study procedures and duration.
- •Participant is a non-smoker or who has not smoked within 2 days prior to the study.
- •Male or female assigned at birth of any race.
排除标准
- •Participant is considered as being morbidly obese (defined as BMI >39.5)
- •Compromised circulation (i.e., Raynaud's Syndrome), injury, open wound, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoos in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
- •Females who are pregnant
- •Females who are trying to get pregnant (with confirmation of positive urine pregnancy test unless the participant is known to be not of child-bearing potential)
- •Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
- •Participants with known respiratory conditions such as: (self-reported)
- •uncontrolled / severe asthma,
- •pneumonia / bronchitis,
- •shortness of breath / respiratory distress,
- •unresolved respiratory or lung surgery,
- •emphysema, COPD, lung disease
- •Recent COVID with or without hospitalization (last 2 months)
- •Participants with self-reported heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
- •high blood pressure: systolic >140 mmHg or diastolic >90 mmHg on 3 consecutive readings (reviewed during health screen)
- •have had cardiovascular surgery, except successful minor surgery without clinical symptoms (i.e., PFO, PDA)
- •chest pain (angina)
- •heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
- •previous heart attack
- •blocked artery
- •unexplained shortness of breath
- •congestive heart failure (CHF)
- •history of stroke
- •transient ischemic attack
- •carotid artery disease
- •myocardial ischemia
- •myocardial infarction
- •cardiomyopathy
- •implantable active medical device such as pacemaker or automatic defibrillator
- •Self-reported health conditions as identified in the Health Assessment Form
- •diabetes,
- •uncontrolled thyroid disease,
- •kidney disease / chronic renal impairment,
- •history of seizures (except childhood febrile seizures),
- •epilepsy,
- •history of unexplained syncope,
- •recent history of frequent migraine headaches,
- •recent symptomatic head injury (within the last 2 months),
- •Cancer requiring chemotherapy, radiation, or current treatment.
- •Participants with known clotting disorders (self-reported)
- •history of bleeding disorders or personal history of prolonged bleeding from injury
- •history of blood clots
- •hemophilia
- •current use of blood thinner: prescription or daily use of aspirin
- •Sickle Cell Trait or Disease
- •Participants with self-reported dermatological conditions at sensor application sites
- •severe dermatitis
- •hyperkeratosis
- •nail fungus
- •Participants with severe contact allergies to standard adhesives, latex, silicone or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
- •Participants with severe allergies to iodine (only applicable if iodine is used)
- 另有 10 项未显示
研究组 & 干预措施
Study Population - 18 to 50 Years
The study population will include a minimum of 36 participants up to a maximum of 72, healthy male and female volunteers of any race, ranging in pigmentation from light to dark.
干预措施: Philips MR400 Pro MRI Patient Monitor (Device)
结局指标
主要结局
SpO2 accuracy
时间窗: March-April 2026
SpO2 accuracy will be evaluated for root-mean-square (rms) difference between the DUT and the reference for the specified SpO2 ranges (70-100%) and by SaO2 decade (90-100%, 80\<90%, 70-\<80%).
次要结局
- Assess Pigmentation(March-April 2026)
研究者
研究点 (1)
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